The FDA continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain. Patients have been reported to overdose on fentanyl when the patch malfunctions and releases toxic amounts of fentanyl to the patient. This can occur due to the patch folding over, heating up, or when the patch leaks. Many of these pain patches have been recalled due to defects that caused overdelivery of the drug to the patient.
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This letter is intended to inform you of actions being undertaken by Davol, a subsidiary of C. R. Bard, Inc.,
The firm has received numerous inquiries from patients who have non-recalled Kugel mesh patches and have had complications related to
MURRAY HILL, NJ — C. R. Bard, Inc. (NYSE-BCR) today announced that it is voluntarily recalling its Bard Composix Kugel
